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Austin Vita
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Gloucester, Gloucestershire
Quality Assurance System Specialist
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Salary: £40000 - £50000 per annum |
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Overview
Quality Assurance System Specialist £40,000 - £50,000 Cambridge Austin Vita have engaged with a leading Medical Devices organisation to recruit for a Quality Assurance Specialist. This company has a great working environment that appreciates and supports people with a good work/life balance, this is supported by their strong staff retention rates and their focus on career progression. They are looking for someone with: Responsibilities: Ensuring compliance with national and international standards and legislation currently ISO13485 and ISO9001. Understanding and experience of CAPA and non-conformance. Experience of Medical Devices Vigilance Reporting. Solid working knowledge of customer complaint investigations and trending activities Working knowledge of ISO14971 Medical Devices Risk Management. Work closely with Technical and Business Managers to manage manufacturing procedures and systems to achieve and maintain current certification. Setting up and maintaining controls and documentation procedures. Liaising with customers' auditors and compliance with customers' specifications. Writing technical and management system reports. Mentoring and coaching both within the Quality Assurance Team and throughout the business to improve the company skillset and understanding of the QMS. Essential requirements of the job: Experience in quality assurance within the medical devices industry. Working knowledge of MDD Currently working with ISO13485 Previously engaged with CAPA Be able to perform internal/supplier audits and support external audits. Desirable requirements of the job: Ideally risk management experience (ISO14971). The successful Quality Assurance System Specialist must have previous experience in the Medical Devices industry and must be able to demonstrate hands-on experience of working to and implementing procedural changes to better meet the requirements of ISO13485. If you are a driven Quality Engineer and meet the criteria listed, please APPLY NOW Quality Assurance System Specialist, Cambridge, £40,000 - £50,000. Austin Fraser is acting as an Employment Agency in relation to this vacancy. Austin Fraser is committed to being an equal opportunities employer, and encourages applications from candidates regardless of sex, race, disability, age, sexual orientation, gender reassignment, religion or belief, marital status, or pregnancy and maternity status. Due to the volume of applications received, we are unable to provide individual feedback to unsuccessful applicants.